Clinical Trial of BioBlock COVID-19 Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived From Bovine Colostrum

• ClinicalTrials.gov Identifier: NCT04916574
• Recruitment Status: Completed
• First Posted: June 7, 2021
• Last Update Posted: June 9, 2021
• Sponsor: Icosagen Cell Factory
• Collaborator: Tartu University Hospital
• Information provided by (Responsible Party): Icosagen Cell Factory

Study Description

Brief Summary:

For an antiviral agent to act as an effective biological barrier on nasal mucosal surface, the formulation preferably has to be maintained on the site of action for several hours, and the nasal spray dispenser can be utilized for administering the solution to the upper respiratory tract. A "first-in-man" clinical study of the nasal spray containing anti-SARS-CoV-2 antibodies derived from bovine colostrum was conducted. The study on healthy volunteers was undertaken to evaluate how long the bovine antibodies would be maintained on the nasopharyngeal surface after administration of nasal spray. In addition, the study enabled to determine which of the two concentrations of antibodies should be used in the final nasal-spray formulation. The volunteers were followed up for 4h after administration of antibody spray and sampling was done at different time-points during this period. The concentration of antibodies from patient samples was measured using ELISA analysis. In addition, as this was a "first-in-man" study any adverse events following the administration of spray were also monitored.

Condition or disease	Intervention/treatment	Phase
SARS-COV2 Infection; Covid19	Other: Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived from Bovine Colostrum	Not Applicable

Detailed Description:

To test the nasal biological availability of the BioBlock® immunoglobulin preparation, 16 healthy volunteers were recruited in the phase 0 clinical trial. The study was conducted in the premises of the Ear Clinic of Tartu University Hospital. The study protocol was approved by Research Ethics Committee of the University of Tartu on March 17, 2021 (No 336/T-1). Written informed consent in accordance with the Declaration of Helsinki was obtained from each healthy volunteer. The study group was divided into two subgroups where the individuals were intranasally administered into both nostrils of BioBlock® formulation which contained either 0.1 mg/mL or 0.2 mg/mL of the colostrum immunoglobulin preparation (n=8 in both study groups). A filter paper with a volume capacity of 15 µL was placed on the medial nasal surface using surgical forceps and it was kept on nasal mucosa for 10 minutes. Following this the BioBlock was administered to the nasal cavity. The nasal mucosal sampling was done at 4 timepoints. The samples were analyzed using a Cow IgG ELISA kit.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 16 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Clinical Trial of Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived From Bovine Colostrum
• Actual Study Start Date: March 20, 2021
• Actual Primary Completion Date: March 28, 2021
• Actual Study Completion Date: June 3, 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: BioBlock® concentration 0.2 mg/mL; BioBlock®: Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived from Bovine Colostrum	Other: Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived from Bovine Colostrum; Concentration of active substance on nasal mucosal surface in time
Active Comparator: BioBlock® concentration 0.1 mg/mL; BioBlock®: Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived from Bovine Colostrum	Other: Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived from Bovine Colostrum; Concentration of active substance on nasal mucosal surface in time

Outcome Measures

Primary Outcome Measures :

1. Antibody concentration dynamics [ Time Frame: 4 hours ]
   Concentration of bovine IgG at different timepoints

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Healthy individuals
• Age 18-80
• Have not been diagnosed with SARS-COV-2 infection (lack of positive PCR test)
• Have not been vaccinated against SARS-COV-2 infection

Exclusion Criteria:

• Pregnancy
• Serious allergic or anaphylactic reactions to medications
• Allergies to milk products
• Ear-nose-throat pathologies (anatomic and diseases)
• Immunodeficiency conditions (cancers, hematologic diseases, HIV, congenital immunodeficiency)
• Viral hepatitis A,B and C
• Upper airway infections
• Autoimmune diseases (diabetes, COPD, asthma, rhinitis, RA, psoriasis)
• Concomitant drugs - glucocorticosteroids, biologic drugs, inhalable medications

Contacts and Locations

Locations

Estonia

Icosagen AS

Tartu, Estonia, 61713

Sponsors and Collaborators

Icosagen Cell Factory

Tartu University Hospital

More Information

• Responsible Party: Icosagen Cell Factory
• ClinicalTrials.gov Identifier: NCT04916574
• Other Study ID Numbers: Ico-CT001
• First Posted: June 7, 2021
• Last Update Posted: June 9, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Antibodies; Immunologic Factors; Physiological Effects of Drugs